Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure

• Proportion of patients alive and dialysis-independent at 100 days [ Designated as safety issue: No ]
  

• Proportion of patients alive and dialysis-independent at 6 and 12 months [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Glomerular filtration rate (calculated or measured) at 15 and 100 days and at 6 and 12 months [ Designated as safety issue: No ]
  
• Change in serum free light chain levels between days 0 and 15 [ Designated as safety issue: No ]
  
• Response of myeloma to treatment at 100 days and at 6 and 12 months [ Designated as safety issue: No ]
  
• Quality of life [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Compare the effect of dexamethasone and cytotoxic chemotherapy with vs without plasma exchange on the likelihood of renal recovery (i.e., dialysis-independent at 100 days) in patients with newly diagnosed multiple myeloma and acute renal failure.

Secondary

• Compare the overall survival of patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.
• Determine the value of renal histology in predicting recovery of renal function in these patients.
• Determine the value of serum free light chain assay in determining disease response and renal function recovery in these patients.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to planned chemotherapy (vincristine and doxorubicin hydrochloride (VA) or VA-like chemotherapy vs thalidomide-containing chemotherapy vs alkylating agent vs other), frequency of chemotherapy courses (1-3 weekly vs 4 weekly), need for dialysis at randomization (yes vs no), and age (< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral dexamethasone, at least twice daily, on days 1-4 and 9-12. Patients undergo plasma exchange by cytocentrifugation or plasmafiltration over 2-3 hours in weeks 1 and 2 (7 treatments total; 4 of them in week 1). Patients then receive planned chemotherapy per local clinician on days 17-100. Chemotherapy may continue after 100 days at the discretion of the local clinician.
• Arm II: Patients receive dexamethasone and planned chemotherapy as in arm I. Quality of life is assessed at baseline, day 100, and 6 and 12 months.

After completion of study treatment, patients are followed at 6 and 12 months and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.